Completed

OMEGAOmacor: Measures of Endothelial Function and triGlyceride Alteration

What is being tested

4/day of 4g P-OM3 capsules

+ 4/day of 1g P-OM3 capsules

+ Corn Oil Placebo, 4 capsules/day for 8 weeks

Drug

Who is being recruted

Hyperlipidemias+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 21 to 65 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: July 2007

See protocol details

Summary

Principal SponsorPenn State University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2007

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Official TitleOmacor: Measures of Endothelial Function and triGlyceride Alteration

NCT00504309

Principal SponsorPenn State University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemiaDyslipidemiasLipid Metabolism Disorders

Criteria

4 inclusion criteria required to participate

triglycerides 150-500 mg/dL

age 21-65 years

generally healthy

body mass index (BMI) 20-39 kg/m2

12 exclusion criteria prevent from participating

smoking

premenopausal (if female)

use of hormone replacement or oral contraceptives

use of lipid lowering or blood pressure medication

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.

Group II

Experimental

1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.

Group III

Experimental

4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).

Group IV

Experimental

4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.

Group 5

Experimental

Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.

Group 6

Experimental

Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Penn State University General Clinical Research Center

University Park, United StatesOpen Penn State University General Clinical Research Center in Google Maps

CompletedOne Study Center